The FDA has approved Zyprexa (olanzapine, from Lilly) tablets for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents 13–17 years of age. This approval follows a favorable vote regarding the safety and efficacy of Zyprexa from the FDA Psychopharmacologic Drug Advisory Committee (PDAC) in June on Lilly’s supplemental New Drug Application for these indications. The PDAC examined findings from two pivotal clinical trials: one six-week trial in adolescents with schizophrenia and one three-week trial in adolescents with manic or mixed episodes associated with bipolar I disorder, as well as extensive Zyprexa safety data relevant to adolescents.
The updated Zyprexa label states that healthcare providers should consider the increased potential for weight gain and hyperlipidemia in adolescents compared to adults and the potential for long-term risks, which in many cases, may lead them to consider prescribing other drugs first. Adolescents were also more likely to experience increased sedation and greater increases in prolactin levels and hepatic transaminase levels. Additionally, the revised Zyprexa label highlights the need for a comprehensive treatment program in pediatric patients and recommends that Zyprexa be used as part of a “total treatment program for pediatric patients with schizophrenia and bipolar I disorder,” which may include psychological, educational and social interventions.
Zyprexa is already indicated in adults for the treatment of schizophrenia, acute treatment of mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar I disorder.
For more information call (800) 545-5979 or visit www.zyprexa.com.